Neuroscience and Brain Stimulation

The Food and Drug Administration has cleared Flow Neuroscience’s FL-100, the first prescription at-home brain‑stimulation device for adults 18 and older with moderate to severe major depressive disorder. The headset uses transcranial direct current stimulation to deliver low‑level electrical current to the prefrontal cortex for about 30 minutes a day, paired with a mobile app and remote clinician monitoring. FDA’s decision relied on a randomized controlled trial, published in Nature Medicine, in which patients receiving active stimulation showed an average 58% improvement in depression symptoms after 10 weeks compared with controls, with many seeing benefits within three weeks. Reported side effects were generally mild, including temporary skin irritation, redness and headaches. Flow says more than 55,000 people have already used the device in Europe, the U.K., Switzerland and Hong Kong, and it expects to make FL‑100 available to U.S. patients by the second quarter of 2026 as a stand‑alone or adjunct treatment alongside antidepressants and therapy.